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NCT00840177 · ClinicalTrials.gov registry record · Phase 2
S0919 Idarubicin, Cytarabine, and Pravastatin in Treating Patients With Relapsed Acute Myeloid Leukemia
A Phase 2 study, sponsored by SWOG Cancer Research Network.
- Completed
- Registry status
- Phase 2
- Development phase
- 115
- Enrollment target
NCT00840177 is a Phase 2 study that has completed, run by SWOG Cancer Research Network. The registered enrollment target is 115 participants.
The verdict
NCT00840177, a Phase 2 study, has completed, sponsored by SWOG Cancer Research Network.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 115 participants
- Enrollment target
Study Summary
RATIONALE: Drugs used in chemotherapy, such as idarubicin and cytarabine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Pravastatin may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Pravastatin may also help idarubicin and cytarabine work better by making cancer cells more sensitive to the drugs. Giving idarubicin and cytarabine together with pravastatin may kill more cancer cells. PURPOSE: This phase II trial is studying how well giving idarubicin and cytarabine together with pravastatin works in treating patients with relapsed acute myeloid leukemia (AML). ADDITIONAL BACKGROUND: S0919 was initially designed for patients with relapsed acute myeloid leukemia (AML), where the patient's preceding remission had lasted ≥ 3 months. The null response rate was 30%. The study closed to accrual on Nov 1, 2012 after meeting the defined criterion for a positive study; and the results are being submitted to the American Society of Clinical Oncology meeting. Based on the promising results from this trial, the trial has now been amended to evaluate this therapeutic regimen in poor-risk patients (patients with newly diagnosed acute myeloid leukemia (AML) arising out of myelodysplastic syndrome (MDS), primary refractory acute myeloid leukemia (AML), and relapsed acute myeloid leukemia (AML) with the patient's preceding remission lasting \< 6 months).
Interventions
- DRUG cytarabine
- DRUG idarubicin
- DRUG pravastatin sodium
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 115 participants |
| Start Date | 2009-12-10 |
| Est. Completion | 2021-10-21 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00840177
The ClinicalTrials.gov registry entry for NCT00840177 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 115 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is SWOG Cancer Research Network, which has 270 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which cytarabine is the first listed.
NCT00840177 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00840177 about?
NCT00840177 is a clinical study titled "S0919 Idarubicin, Cytarabine, and Pravastatin in Treating Patients With Relapsed Acute Myeloid Leukemia". RATIONALE: Drugs used in chemotherapy, such as idarubicin and cytarabine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Pravastatin may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. ...
What is the current status of trial NCT00840177?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 115 participants. The study started on 2009-12-10. Estimated completion is 2021-10-21.
What interventions are being tested in trial NCT00840177?
The interventions under investigation include: cytarabine (DRUG), idarubicin (DRUG), pravastatin sodium (DRUG).
Who is sponsoring clinical trial NCT00840177?
This trial is sponsored by SWOG Cancer Research Network, which has 270 total clinical trials registered on ClinicalTrials.gov.
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